Clinical Laboratory
A clinical laboratory is a laboratory where tests are done on clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease.
Clinical laboratories are at the forefront of the personalized medicine trend. However, they are also targets for cost-cutting measures by payers, and increased regulation by CMS and FDA, making the industry a challenging one in which to succeed.
Laboratory medicine is generally divided into two sections, each of which being subdivided into multiple units. These two sections are:
- Anatomic pathology: Units included here are histopathology, cytopathology, and electron microscopy. Other disciplines pertaining to this section include anatomy, physiology, histology, pathology, and pathophysiology.
- Clinical pathology, which includes:
- Clinical Microbiology: This encompasses five different sciences. These include bacteriology, virology, parasitology, immunology, and mycology.
- Clinical Chemistry: Units under this section include instrumental analysis of blood components, enzymology, toxicology and endocrinology.
- Hematology: This section consists of automated and manual analysis of blood cells.
- Genetics is also studied along with a subspecialty known as cytogenetics.
- Reproductive biology: Semen analysis, Sperm bank and assisted reproductive technology.
Credibility of medical laboratories is paramount to the health and safety of the patients relying on the testing services provided by these labs. The international standard in use today for the accreditation of medical laboratories is ISO 15189. Under their respective approaches to laboratory licensure and accreditation, many countries have legal requirements that medical laboratories must be accredited to ISO 15189. This is not true in the United States.
In the United States, there are federal and state laws that address the licensure and accreditation of medical laboratories. Accreditation is done by the Joint Commission, College of American Pathologists, AAB (American Association of Bioanalysts), and other state and federal agencies. CLIA 88, the Clinical Laboratory Improvement Amendments, also dictate testing and personnel.
In addition, many clinical laboratories have adopted quality management programs such as Six Sigma and Lean quality to improve clinical quality, reduce turnaround time, cut costs, and boost productivity. Lean and Six Sigma are both process improvement methodologies. At a very basic level, Lean is about speed and efficiency, while Six Sigma is about precision and accuracy, leading to data-driven decisions. Lean and Six Sigma methods are finding numerous applications in anatomic pathology laboratories and pathology group practices.
Quest Diagnostics Earns $3 Billion in Q2, Its Best Quarter Ever
CEO Summary: Quest Diagnostics reported its best quarterly revenue in history, and Labcorp also logged a very successful Q2 2026. Both companies attributed growth to higher test requisition volumes and an increasing emphasis on specialt…
Labcorp Expands Reach into Rural and Native American Healthcare
CEO Summary: Clinical laboratories will want to note Labcorp’s expansion into rural healthcare through its recent acquisition of Native American-owned Tribal Diagnostics and new partnership with a community health center network….
New Report Outlines Barriers to Alzheimer’s Blood Tests
CEO summary: Experts convened by the Milken Institute, a nonpartisan think tank, assessed the readiness of the US healthcare system to adopt blood-based markers to aid in diagnosis of Alzheimer’s disease. They identified payer accepta…
Alzheimer’s Data-Sharing Platform Hints at Lab Opportunities
CEO SUMMARY: Savvy clinical lab decision-makers know that they must seek out new revenue streams beyond expanded test menus. Labcorp’s new AI platform for Alzheimer’s disease-related data ana…
Labcorp and Quest Execs Support RESULTS Act Progress
Chief executives at both Labcorp and Quest Diagnostics reported year-over-year revenue growth in the first quarter during recent earnings calls, especially in specialty and consumer testing. They also indicated the companies are watching the progress of the RESULTS Act in Congress in hopes that it wi…
Positioning the Lab as a Strategic Powerhouse
CEO SUMMARY: The 31st Annual Executive War College in New Orleans showcased speakers who have re-imagined the diagnostic laboratory’s role from back-office utility to a primary driver of system-wide strategy and clinical excellence. A consistent theme came up during doze…
Artificial Intelligence Briefs
NYC Health CEO Suggests Replacing Radiologists with AI Anatomic pathologists may find concern in the words of Michael H. Katz, MD, the CEO at NYC Health + Hospitals, who indicated the system is prepared to substitute AI for radiologists in ce…
In Earnings Calls, Execs at Quest and Labcorp Push for RESULTS Act
Chief executives at Labcorp and Quest Diagnostics made it clear during recent investor calls that they want Congress to pass the RESULTS Act. The Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act is seen b…
Translating Genomic Testing to the Clinic
CEO SUMMARY: An entrepreneur in the liquid biopsy sector outlines a series of questions to answer if a diagnostic innovation is to ever succeed in the commercial marketplace. Scientists and businesspeople will want to ask about a potential product’s significance, uniquen…
Bringing Lab Testing to Hybrid Care Locations
CEO SUMMARY: Clinical laboratory testing plays an important role in individual urgent care and emergency sites, but when such services are offered under one roof, planning for lab tests, related equipment, and CLIA provisions becomes more complicated. TriCore shares its ex…
CURRENT ISSUE
Volume XXXIII, No. 11 – September 2026
In the September 2026 briefing, The Dark Report digs into a CMS proposal to cut payments for CPT code 88305, potentially based on flawed thinking. Other coverage includes the evolving role of mass spectrometry in clinical labs, payer obstacles to blood-based biomarker tests for Alzheimer’s disease, and how young pathologists can get business skill help.
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